1. Field
A biomarker for predicting an effect of an anti-c-Met antibody and/or selecting a subject for application of an anti-c-Met antibody, a reference (or control) marker for comparison of gene expression level, a method of predicting an effect of an anti-c-Met antibody and/or selecting a subject for application of an anti-c-Met antibody including measuring a level of the biomarker in a biological sample, and a method of preventing and/or treating a cancer including administering an anti-c-Met antibody to the selected subject, are provided.
2. Description of the Related Art
After the U.S. Food & Drug Association (FDA) approved Herceptin, a targeting drug produced by Genentech Inc., various individual therapies and markers for selecting an applicable subject have been developed. In the case of Herceptin, a subject suitable for application can be selected through the expression amount of HER2 growth factor receptor expressed on cell membrane of cancer cells. After development of the IHC (immunohistochemistry) assay, various assays, such as FISH (fluorescence in situ hybridization), CISH (chromogenic in situ hybridization), and the like, have been employed for selecting a suitable subject. Thereafter, EGFR mutation as an selection marker of a subject (lung & pancreatic cancer patient) for application of Erlotinib, KRAS mutation as an selection marker of a subject (colorectal cancer) for application of Vectibix and Erbitux, and the like, have been approved by FDA.
For an anticancer agent targeting c-Met protein, markers for a subject on which the c-Met targeting agent can exhibit its effect well have been studied. Currently, a c-Met targeting agent, MetMab, is a subject of a phase III clinical trial, wherein ventana IHC assay (sp44: c-met primary antibody, rabbit monoclonal) has been used as a co-diagnosing method for selecting a suitable subject. However, such diagnosing method is limited in its use as a general diagnostic due to a low accuracy. In addition, such IHC assay has a weak point that the results depend on individual properties, lesion, propensity of pathologist, and the like.
In order to increase the effect of c-Met targeting anticancer agent, development of biomarkers for predicting the effect of the targeting anticancer agent or selecting a subject suitable for application of the targeting anticancer agent is needed.